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Ratified by: Bedfordshire and Luton Joint Prescribing Committee December 2019 Review date: December 2021 Author: Luton and Bedfordshire Paediatric Dietetic services (acute and community)

Contents Page

Introduction and volumes to prescribe 2

Summary guide to specialist formula prescribing and purchase only formula (OTC) 3,4

Quick reference summary – common feeding concerns in babies 5

Cow’s milk allergy 6,7

Pre-term 8

Faltering growth 9

Gastro-oesophageal reflux 10

Secondary lactose intolerance 11

Acknowledgement and version amendments 12

References 13

Guidelines for the prescribing of

specialist infant formula in primary care:

Luton and Bedfordshire

December 2019

This document is a revised edition written and agreed by Paediatricians,

Paediatric Dietitians, GPs and Medicine Optimisation Teams within Luton and

Bedfordshire Clinical Commissioning Groups.

.

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Introduction

Volumes of feed to prescribe infants

Age of infant Number of tins for 28 days

Under 6 months 10 x 400g OR 9 x 450g tins OR 6 x 800g tins

Between 6 – 12 months 7 x 400g tins OR 6x 450g tins

Over 1 year

7x 400g OR 6 x 450g tins OR other as stated on prescription request from paediatric dietitian

Whilst these guidelines are for specialist infant formula, breast milk is the optimal milk for

infants. Breastfeeding should be promoted and encouraged where possible.

This guideline aims to provide information to GP’s and Health Visitors on the use of prescribable

infant formulae. It provides guidance on initial and on-going prescribing and when to discontinue

prescribing.

The guideline covers formula to prescribe from birth to 1 year of age. Some conditions may require

formula to be prescribed beyond this age and this will be referenced under ‘Review Criteria’.

Specific exceptions: If all nutrition is received by a feeding tube e.g. NG/NJ/PEG for clinical

reasons (such as an unsafe swallow), a dietitian will recommend a prescription for the appropriate

monthly amount and type of formula. A dietitian may calculate a different volume or suggest the

use of a formula outside these guidelines based on individual need. The specific need and clinical

rationale will be included with the feed prescription request.

Please use the guide below to estimate quantity of formula to prescribe. Volumes stated are the

maximum that are required for an average child (on the 50th percentile for weight); however, those

under the care of a dietitian may require more or less formula. Over prescribing can occur if infants

are being overfed. If you suspect an infant is being overfed or a parent requires support on

responsive feeding refer to the health visiting team for assessment.

Initially prescribe a 1 week trial of 2-3 x 400g or 450g tins or 1 x 800g tin;

to see if the infant will accept it

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Summary Guidelines for the Prescribing of Specialist Infant Formula’s in Primary Care December 2019

Diagnosis Guidance Age range Formula Vol. <

6mths for 28 days

Vol. > 6mths for 28 days

Review criteria

Cow’s Milk Allergy (CMA)

(page 6&7)

First Line Extensively Hydrolysed

Formula

(EHF) to be used first line if

mild to moderate milk

allergy suspected.

Birth to 1-2 years

1st

line EHF primary care

Similac Alimentum

(Abbott Nutrition)

Casein based Lactose free

Other EHF formulas maybe initiated by secondary or specialist care.

10 x 400g

7x 400g Children prescribed any specialist infant formulae should be reviewed every 6

months.

Prescribe up to 2yrs of

age or until age-appropriate alternative milk is advised/child tolerates cow’s milk.

Children with multiple allergies may require prescribed specialist

infant formula up to 2 yrs of age.

Amino Acid based formula

Preferably started in

secondary care for multiple

allergies, severe non IgE

mediated allergies or IgE

mediated allergy.

Birth to 2 years

1st

line primary care

Alfamino

(SMA Nutrition) (v)

10 x 400g 7x 400g

Other amino acid based formulas maybe initiated by secondary care.

Including:

Puramino

Neocate LCP

Neocate Syneo

Specialist follow on formulas

Over 1 year

Neocate Junior

(Nutricia) (h)

Nutramigen 3

(Mead and Johnson)

Quantity to be advised following

assessment

Quantity to be advised following

assessment

These products are only to be issued on written request from a paediatric dietitian.

Pre-term (page 8)

Specialist formula.

Only start in secondary care

Birth to 3-6 months

corrected age

Nutriprem 2 Powder

(Cow & Gate)

6 x 800g

n/a

Do not issue liquid formulations as there is

no clinical benefit. SMA Gold Prem 2

(SMA Nutrition) 10 x 400g n/a

Faltering Growth (page 9)

Specialist

High energy formula.

Only start in secondary or

specialist care

Birth to 1

year

Up to 18

months of age or 8kgs body weight.

Infatrini

(Nutricia) (h)

Quantity to be advised following

assessment

Quantity to be advised following

assessment

Review recent assessment report

from paediatrician or paediatric Dietitian.

SMA High Energy

(SMA Nutrition)

Similac High Energy

(Abbott Nutrition) (h) (v)

Note: The guidelines are intended for use in primary care, if clinically indicated an alternative product may be requested by secondary or

specialist care. The clinical rationale will be stated in written correspondence.

KEY

(v) suitable for vegetarians ((h) halal approved (ve) suitable for vegans.

Use as first line extensively hydrolysed formula (EHF).

Preferably started in secondary or specialist services. If started in primary care, refer patient to acute service for assessment with paediatrician and specialist dietetic support

Over the counter only- parents/carers need to purchase from supermarket or local pharmacy

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Summary of Guidelines for Specialist Infant formula’s (TO BE PURCHASED BY PARENT/CARER) December 2019

Diagnosis

Guidance

Age range

Formula Considerations for use

Anti-Reflux

To be used under medical supervision (Food for special medical purposes)

Birth to 1 year

SMA Anti-Reflux

(SMA Nutrition)

Cow and Gate Anti-Reflux

(Cow and Gate) (h)

Aptamil Anti-Reflux

(Nutricia)

HIPP Organic Anti-Reflux

(HIPP)

Advise parents to make feeds according to manufacturer instructions (note preparation differs between brands and a fast flow teat may be required) Do not use anti-reflux formula with other thickener products (e.g. carbel) or antacids. If anti-reflux formula is unsuccessful in resolving symptoms stop the formula and consider starting alginate therapy as per NICE guidance.

Lactose free

To be used under medical supervision (Food for special medical purposes)

Birth to 1 year

Aptamil Lactose Free

(Nutricia)

SMA Lactose Free

(SMA Nutrition)

Not suitable for infants with suspected cow’s milk protein allergy Should only be used for a maximum of 6-8 weeks After 1 year can use shop bought full fat lactose free milk

Soya

(May be

advised in exceptional

cases of cow’s milk allergy see

page 7)

To be used under medical supervision (Food for special medical purposes)

6 months to 1 year

SMA Wysoy

SMA Nutrition)

Soya formula should only be used after 6 months of age if the first line extensively hydrolysed formula is not accepted due to taste. Soya formula may be advised for infants diagnosed with galactosaemia Unsuitable for infants who have reacted to soya traces in food.

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Quick reference summary: common feeding concerns in babies

First line advice for parents/carers (taken from NHS choices website)

Vomiting

Carry on breastfeeding/bottle feeding baby. If being sick, try giving small feeds more often than usual

Give babies on formula or solid food small sips of water between feeds

Do not make baby formula weaker – use it at usual strength Medical review: Signs of dehydration or vomiting occurring longer than 2 days

Regurgitation/ Reflux

Get advice re: baby’s position during and after breastfeeding or bottle feeding

Hold baby upright for as long as possible after feeding

Smaller more frequent feeds if formula fed (check not exceeding 150mlskg/day – divide total mls a day by latest weight)

Make sure baby sleeps flat on their back (should not sleep on their side or front) Medical review: Not improving after 2 weeks of trying things to ease reflux, gets reflux for the first time after 6 months of age, older than 1 year, not gaining weight, feed refusal

Constipation

Can occur when baby starts taking formula or processed foods

If baby is formula fed, offer extra drinks of water between feeds – do not add more water to formula feeds.

Breastfed babies rarely get constipated, continue to offer breast milk

Try gently moving baby’s legs in a bicycle motion or careful massaging the tummy to stimulate the bowels

Sometimes it can take a few weeks for symptoms to improve. Medical review: Not improving with first line advice, blood in stool, poor weight gain

Diarrhoea

Carry on breastfeeding/bottle feeding baby. If also being sick, try giving small feeds more often than usual

Give babies on formula or solid food small sips of water between feeds

Do not make baby formula weaker – use it at usual strength Medical review: Signs of dehydration or diarrhoea continues longer than 7 days

Colic

(Crying more than 3 hours a day, 3 days a week for at

least 1 week)

Seek advice and support from a health visitor

Hold or cuddle baby when they are crying a lot

Sit or hold baby upright during feeding to stop them swallowing air

Wind baby after feeds

Bath baby in a warm bath Have some white noise in the background to distract them Keep feeding baby as usual

Note: There is very little evidence for anti-colic drops and probiotic supplements, changes to maternal diet if breastfeeding, spinal manipulation or cranial osteopathy. Medical review: If first line strategies are not improving symptoms, parent/carer finding it hard to cope, baby is older than 4 months of age

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Cow’s milk allergy (CMA)

Mild to Moderate non IgE Mediated Symptoms

Severe non IgE mediated Symptoms Severe IgE Mediated Symptoms

Mostly 2-72 hours after ingestion of

Cow’s milk protein. Usually several of these symptoms will be present, symptoms persisting despite first line measures are likely to be allergy related:

Gastrointestinal – persistent

irritability ‘colic’ reflux (GORD), vomiting, food refusal or aversion, diarrhoea like stools, constipation especially soft stools with excessive straining, abdominal discomfort, painful flatus blood/mucous in stools otherwise well infant.

Respiratory -“catarrhal airway

signs”.

Skin- significant atopic eczema,

pruritus (itching) erythema (flushing) non-specific rashes, moderate persistent atopic dermatitis

The symptoms above are very common in otherwise well infants so clinical judgement is required. Trial exclusion diets must only be considered if history and examination strongly suggest cow’s milk allergy especially in breastfed infants. TREATMENT SUMMARY: Exclusively breastfeeding mother

Trial strict exclusion of all cow’s milk from her own diet and advise to take calcium and vitamin D for 2-4 weeks. Find diet sheet here

Formula-fed or ‘mixed feeding’

If mother unable to revert to fully breastfeeding, trial extensively hydrolysed formula first line Similac Alimentum for 2-4 weeks. Complete iMAP home challenge to confirm diagnosis after elimination trial Find here then refer to paediatric dietitian Refer to iMAP (2019) for treatment guidelines. Find here

Mostly 2-72 hours after ingestion of

Cow’s milk protein. One but usually more of these severe, persisting and treatment resistant symptoms:

Gastrointestinal – Diarrhoea,

vomiting, abdominal pain, food refusal or food aversion, significant blood and/or mucus in stools, irregular or uncomfortable stools with/without faltering growth

Skin – severe atopic dermatitis

with/without faltering growth TREATMENT SUMMARY Exclusively breastfeeding mother

Trial strict exclusion of all cow’s milk from her own diet and advise to take calcium and vitamin D for 2-4 weeks. Find diet sheet here Formula-fed or ‘mixed feeding’

If mother unable to revert to fully breastfeeding, trial extensively hydrolysed formula first line Similac Alimentum for 2-4 weeks. URGENT REFERRAL TO LOCAL ALLERGY SERVICE (Includes dietitian) Refer to iMAP (2019) for treatment guidelines. Find here

Mostly within minutes of ingestion of Cow’s milk protein or up to 2 hours

after.

Anaphylaxis – immediate

reaction with severe respiratory or cardiovascular signs and symptoms (rarely a severe gastrointestinal presentation)

One but usually more of these severe, persisting and treatment resistant symptoms:

Gastrointestinal - vomiting,

diarrhoea, abdominal pain/colic.

Skin- acute pruritus, erythema,

urticaria, angioedema or acute “flaring” of persisting atopic dermatitis.

Respiratory- rarely in isolation of other symptoms

acute rhinitis and/or conjunctivitis

TREATMENT SUMMARY

Exclusively breastfeeding mother

Trial strict exclusion of all cow’s milk from her own diet and advise to take calcium and vitamin D for 2-4 weeks Find diet sheet here Formula-fed or ‘mixed feeding’

If mother unable to revert to fully breastfeeding, trial extensively hydrolysed formula first line Similac Alimentum for 2-4 weeks

URGENT REFERRAL TO LOCAL ALLERGY SERVICE (Includes dietitian) Refer to iMAP (2019) for treatment guidelines. Find here

DIAGNOSIS:

Cow’s milk allergy (CMA) suspected after taking an allergy focused history as per NICE Food allergy in

children. Find here

Lactose free formulas are not suitable for treating CMA as they contain cow’s milk protein (see

secondary lactose intolerance on page 10)

Refer to local cow’s milk allergy pathway or iMAP guideline (2019) for clinical advice on diagnosing

and managing cow’s milk allergy in primary care. Find here

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GP REVIEW CRITERIA:

An extensively hydrolysed formula (EHF) can be prescribed up to the age of 2 years, however, some

children may tolerate a plant based milk alternative over 1 year of age and their prescription formula

can be stopped. Refer to the latest written correspondence from a Paediatric Dietitian for guidance.

All patients prescribed these formulas require a regular review by a Paediatric Dietitian for advice on

calcium intake, challenging with cow’s milk using the milk ladder and other feeding issues relating to a

restricted diet.

Prescribing criteria Age range Recommended formula Clinical Indications

FIRST LINE

Extensively hydrolysed formula

(EHF)

Birth to 1 - 2 years

1st line primary care

Similac Alimentum (Abbott Nutrition)

Casein based Lactose free

Other EHF formulas maybe initiated by secondary or specialist care.

Suspected or diagnosed cow’s milk allergy.

AMINO ACID

Formulas

Preferably started in specialist or secondary

care

Birth to 2 years

1st

line secondary care:

Alfamino

(SMA Nutrition) (v)

Use if symptoms have not

resolved on EHF.

Do not use if extensively

hydrolysed formula is not

accepted simply based on

taste, contact the dietetic

team for advice on alternative.

Other amino acid based formulas maybe initiated by secondary care.

Including:

Puramino

Neocate LCP

Neocate Syneo

Specialist milk over 1 year

Over 1 year

Neocate Junior

(Nutricia)

Nutramigen 3

(Mead and Johnson)

These products are only to be issued on written request from

a paediatric dietitian.

OVER THE COUNTER

- NOT TO BE

PRESCRIBED

Soya infant formulas

only

6 month to 1 year SMA Wysoy

(SMA Nutrition) (v) (h)

Soya formula should only be used after 6 months of age

and if the first line EHF is not accepted due to taste.

If the child presents with a suspected CMPA over 1 year

of age, and there are no growth concerns, Calcium

fortified nutrient enriched no added sugar plant based

milks can be purchased in most supermarkets. Refer to dietetic team for assessment.

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Pre-term infants

Prescribing criteria Age range Recommended formula

SECONDARY CARE

Formula that should only be started in secondary care.

Use up to 3 months corrected age* but can be prescribed up to

6 months corrected age*.

Nutriprem 2 Powder

(Cow and Gate)

SMA Gold Prem 2 Powder

(SMA Nutrition)

* Corrected age: Corrected age is the actual age minus the number of weeks premature.

DIAGNOSIS:

Infants born before 34 weeks gestation and weighing less than 2kg at birth are considered pre-term and

may be discharged from hospital on a pre-term nutrient enriched discharge formula.

TREATMENT SUMMARY:

Any infant discharged on these formulas will require growth monitoring (weight, length and head

circumference) by the health visiting team.

Please note pre-term infants can occasionally be discharged on the liquid formulations (Nutriprem 2

or SMA Gold Prem 2) from hospitals out of area. There are no clinical benefits to using liquid

formulations.

Do not prescribe liquid formulations in the community due to significant cost implications.

GP REVIEW CRITERIA:

Pre term formula can be stopped at 3- 6 months corrected age if there is excessive or rapid weight

gain. If stopped under 6 months of age, vitamin supplementation will be required in line with local

guidelines. Find east of england neonatal network iron and vitamin guidance here

All pre-term formulas should be stopped by 6 months corrected age and parents advised to start a

standard infant formula.

If there are concerns regarding an infant’s growth on return to standard formula, request review with

acute team (including a paediatric dietitian).

For pre-term starting solids advice refer to the Bliss website. Find here

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GP REVIEW CRITERIA:

Clinical effectiveness of the supplements should be assessed by regular growth monitoring and

assessment.

Once catch up growth has been achieved the high energy formula should be stopped to prevent

excess weight gain.

If consuming full therapeutic dose and failing to gain or achieve expected growth, consider a referral

to a Paediatrician for further investigation.

Faltering growth

Prescribing criteria Age range Recommended formula

SECONDARY CARE

High energy formula to be started in secondary or

specialist care.

From birth to 18 months or 8 kg body weight.

Infatrini (Nutricia) (h)

SMA High Energy (SMA Nutrition)

Similac High Energy (Abbott Nutrition) (h)(v)

DIAGNOSIS:

NICE Faltering Growth-recognition and management (2017) Find here

A weight, length and ideally head circumference are required for diagnosis. Faltering growth is defined by one of the following criteria:

A weight of an infant falls below the bottom centile (0.4th)

A downward fall through 2 or more centiles for weight or head circumference

A difference of height and weight of more than two centiles

Note: It is not possible to detect growth faltering without using appropriate growth charts.

TREATMENT SUMMARY:

It is important to consider the reason for faltering growth e.g. iron deficiency anaemia, GORD or a

child protection issue and treat accordingly or refer to a paediatrician.

In breast fed infants consider a referral to a breastfeeding advisor for assessment and support with

expressed breast milk top ups.

Consider a referral to the health visiting team for behaviour management advice if infant is over 6

months old, eating solid food and exhibiting fussy eating behaviour.

Before commencing a high energy formula ensure parents or carers are offered advice on suitable

high calorie foods if the infant is over 6 months old.

When commencing a high energy formula please ensure the full recommended prescribed dose is

issued and consumed every day to maximise energy intake for weight gain.

All infants on a high energy formula will need regular growth monitoring from the health visiting

team (weight, length or height and head circumference) to ensure catch up growth is achieved and

appropriate discontinuation of formula to minimise excessive weight gain.

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Gastro-oesophageal reflux DIAGNOSIS:

Gastro-oesophageal reflux (GOR) is the passage of gastric contents into the oesophagus, with or without vomiting. It is very common (at least 40%) of normal, healthy infants. Infants presenting with GOR usually do not require investigation or treatment. Parents and carers should be reassured that this is a common process which becomes less frequent with time. Advise parents to return for a review if there are new concerns. Find healthcare professional factsheet here

The presence of “red flags” may indicate disorders other than GOR. Refer to NICE GORD in children and young people diagnosis and management (2015) Find here

TREATMENT SUMMARY:

A diagnosis of gastro-oesophageal reflux disease (GORD) is warranted when reflux of gastric contents causes complications serious enough to require medical treatment (i.e frequent regurgitation and marked distress) Initial first line advice for parents: Breastfed babies: Continue breastfeeding refer baby to health visitor for a breastfeeding assessment and support with positioning before and after feeding. Alginate therapy maybe appropriate if symptoms persist. Formula fed babies:

Check total volume is not exceeding 150mls/kg/day

Try offering smaller more frequent feeds

Give advice regarding positional management to treat GOR Find parent factsheet here

Refer to health visitor for feeding assessment and support

If all the above strategies have not been effective in treating regurgitation, consider a trial of 1-2 weeks on a thickened formula.

GP/Health Visitor Review Criteria

Refer to paediatrician if reflux continues over 1 year of age

Review after 1 month, if no improvement in symptoms may need further investigation by a

paediatrician.

TO BE PURCHASED BY PARENT/CARER

Age range Recommended formula

Formula to be purchased by family from supermarket

or pharmacy

To be used under medical supervision

(Food for special medical purposes)

Birth to 1 year

(Trial stopping formula at regular intervals as

90% of infants will outgrow GORD by 12

months)

SMA Anti-Reflux (SMA Nutrition)

Cow and Gate Anti-Reflux

(Cow and Gate) (h)

Aptamil Anti-Reflux (Nutricia)

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Secondary lactose intolerance Diagnosis:

Usually occurs following an infectious gastrointestinal illness, symptoms include abdominal bloating, increased (explosive) wind and loose green stools for longer than 2 weeks.

Secondary lactose intolerance should be suspected in infants who have had symptoms that persist for more than 2 weeks.

Diagnosis is usually the resolution of symptoms within 48 hours once lactose is removed from the diet.

Primary lactose intolerance is less common than secondary intolerance and does not usually present until later childhood or adulthood

Find healthcare professional factsheet here

Treatment Summary (if symptoms have persisted longer than 2 weeks)

Breastfeeding – continue with usual feeding as no change to maternal diet will be effective, breast feeding remains optimal for the baby.

Replace standard formula with a Lactose free formula for up to 8 weeks, allow symptoms to resolve then reintroduce standard formula/milk products slowly into the diet. Find parent factsheet here

If symptoms persist over 1 year of age then stop the formula, advise on a full fat lactose free supermarket milk and encourage return to a normal diet. Avoiding lactose long term is not recommended.

Note: the use of lactase drops i.e colief is not recommended as there is no evidence base

GP/Health Visitor Review Criteria

If symptoms have not resolved after 8 weeks on lactose free formula/ lactose free diet consider alternative diagnosis e.g cow’s milk allergy or refer to paediatrician for assessment

To be purchased Age range Recommended formula

Formula to be purchased

by family from supermarket or pharmacy

To be used under medical

supervision (Food for special medical

purposes)

Birth to 1 year

(children over 1 year can purchase a shop bought full fat lactose free milk if

still indicated )

Aptamil Lactose Free

(Nutricia)

SMA Lactose Free (SMA Nutrition)

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Amendments from 2017 to 2019 version

Amendment Rationale

Lactose free, soya, anti-reflux formula added back into guidelines

Feedback from primary care for details of over the counter formula as unclear on when these products should be used

Quick reference summary -common feeding concerns in babies

Variation in practice within primary care for common infant feeding concerns e.g constipation. To consider first line advice before starting a specialist formula if diagnosis is unclear.

Summary guide to appropriate prescribing of specialist formulas

Summary of guidance for most common clinical conditions where a specialist formula is being inappropriately prescribed.

Removed supporting documents New hyperlinks added to document for easier access to supporting documents.

2nd line EHF removed Prior to commencing alternative eHf primary care professionals should seek guidance from secondary or specialist service as the majority of infants should tolerate the first line EHF if the underlying diagnosis is non IgE mediated cow’s milk protein allergy.

Acknowledgements

Luton Clinical Commissioning Group Bedfordshire Clinical Commissioning Group Consultant Paediatricians Luton and Dunstable University Hospital Paediatric Dietetic Team Bedford Hospital Trust Paediatric Dietetic Team Luton and Dunstable University Hospital Trust Community Paediatric Dietetic team Bedfordshire Community Health Services Health Visiting Team Bedfordshire and Luton Community Health Services Paediatricians Bedford Hospital Trust An assessment framework was used to compile details of infant formulae available at time of review and subsequent recommendations for the prescribing guidelines. This document is available upon request. Date ratified by The Bedfordshire and Luton Joint Prescribing Committee: December 2019

Date for review: December 2021

Contact Details

Bedfordshire Community Health Services Dietetic Department Dunstable Health Centre Priory Gardens Dunstable LU6 3SU Tel: 01582 707400 Email: ccs.beds.nutrition@nhs.net

Luton & Dunstable Hospital Dietetic Department Lewsey Road Luton LU4 0DZ Tel: 01582 497544 Email: dietitians.department@nhs.net

Bedford Hospital Dietetic Department South Wing Kempston Road Bedford MK42 9DJ Tel: 01234 792171 Email: bhn-tr.dietitiansbedford@nhs.net

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Available at: https://www.firststepsnutrition.org/composition-claims-and-costs

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Available at: https://www.networks.nhs.uk/nhs-networks/eoe-neonatal-odn/guidelines/current-guidelines

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Young, L et al (2012) ‘Nutrient-enriched formula vs standard term formula for preterm infants following hospital discharge (review)’ The Cochrane Library.

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